NINDS Policy on Monitoring NINDS-Supported Clinical Research

The National Institute of Neurological Disorders and Stroke (NINDS) supports clinical research and must ensure compliance with laws and government regulations including procedures to protect the safety of all participants.

To assist the NINDS in properly monitoring such research, additional information is required from the Principal Investigator beyond what is normally submitted with a competitive application or proposal and the annual noncompetitive renewal application or annual report. This document provides additional guidance regarding the NINDS policy and reporting requirements on monitoring clinical research projects.

Awardees must comply with the Terms of Award that will be incorporated into their Notice of Grant Award. The NINDS Terms of Award for Clinical Research delineate Awardee responsibilities including submission of required documentation to the NINDS. These Terms apply to all NINDS-supported clinical research involving human subjects, which is defined as:

Patient-oriented research including the development of new technologies using human subjects or materials derived from patients or volunteers, as well as studies into the mechanisms of human disease using patient or volunteer samples, and therapeutic interventions, clinical trials, and any studies that require Institutional Review Board/Ethics Committee (IRB/EC) approval to collect samples from patients or volunteers;

Epidemiologic and behavioral studies; and

Outcomes and health services research.

In addition to the Terms of Award pertaining to all clinical research, there are special Terms that apply to all clinical trials and to all Phase III clinical trials. A clinical trial is defined as clinical research involving the administration of an intervention (drug, biologic, surgery, device, behavioral counseling, lifestyle modification, etc.) to living human beings for the purpose of evaluating some aspect of the intervention. A Phase III clinical trial evaluates the efficacy of an intervention in a large group of human subjects by comparing the experimental intervention to standard treatment or no treatment, or by comparing combinations of two or more existing treatments.

These Terms of Award define specific timelines for approvals related to the initiation of the research and timelines for reporting events related to the progress of the research. It is the responsibility of the Awardee to submit the required documentation and information to the NINDS according to these timelines.

NINDS-supported clinical research must adhere to all Federal and State regulations regarding the protection of human subjects. Clinical research conducted outside of the U.S. must also comply with the relevant regulations of the host Country. Whenever the regulations differ between authorities, the more restrictive regulations will apply.

Please review the NIH information and guidance on human subject protection, informed consent, and IRB/EC. Studies must comply with the universally accepted principles of Good Clinical Practice (GCP) as outlined in Title 21 of the CFR.